Phase 2 Study of Tarlatamab, a DLL3-Targeted T-cell Engager, for Adults With Relapsed Advanced Extrapulmonary Neuroendocrine Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma EPNEC who previously received platinum-based chemotherapy. This phase 2, open-label, single-arm study targets EPNECs, which are rare and aggressive cancers with limited second-line treatment options. Tarlatamab targets the DLL3 protein, which is highly expressed in these cancers, offering a potential novel therapy for patients with poor prognosis. Participants will receive tarlatamab through intravenous infusions starting with a 1 mg dose on Cycle 1 Day 1, then 10 mg doses on Day 8 and Day 15 of Cycle 1, followed by 10 mg every two weeks thereafter. The study includes two cohorts based on cancer origin gastrointestinal and pancreaticobiliary, and genitourinary, with identical dosing schedules. There is no placebo group, and treatment continues until disease progression or other criteria. During the study, participants undergo a 21-day screening period followed by treatment and a safety follow-up visit, then long-term follow-up monitoring. Researchers will assess tumor response using RECIST 1.1 criteria and measure outcomes such as objective response rate, progression-free survival, overall survival, and duration of response. Participants receive regular evaluations including imaging scans and clinical assessments to monitor disease status and safety throughout the study period, which may last up to 36 months.

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients